For its clinical module, Epigenomics will need to demonstrate that Epi proColon performs at least as well as fecal immunochemical testing, it said, adding that it has been in discussions with FDA about the design for its clinical study, which it expects to initiate in the coming months after the study's protocol has been finalized.
The clinical module for the PMA submission will include results of the head-to-head comparison with fecal immunochemical testing, previously announced data from a clinical validation study in a cohort of prospectively collected samples, and other clinical study results.
Last month, the Berlin, Germany-based molecular diagnostics firm announced clinical validation study results for the test. The test demonstrated 68 percent sensitivity and 80 percent specificity.
